The new program will convene experts from the regulator’s offices for a team-based review, instead of using the standard review system, where a drug application is sent to numerous FDA offices. | Photo Credit: REUTERS/ANDREW KELLY
The regulator said it has selected Merck KGaA’s fertility drug Pergoveris, Sanofi’s Type 1 diabetes drug teplizumab, Regeneron’s DB-OTO for deafness and ketamine for domestic manufacturing of a general anesthetic.
These will have shorter review times compared to the typical timeline of about 10-12 months.
The FDA’s list also includes Revolution Medicines’ RMC-6236 for pancreatic cancer, Disc Medicine’s bitopertin for porphyria, Achieve Life Sciences’ cytisinicline for nicotine vaping addiction as well as Dompe’s cenegermin-bkbj for blindness and augmentin XR for domestic manufacturing of a common antibiotic.
Shares of Revolution rose 7.4%, while Disc Medicine rose 19% in extended trading.
The FDA in June launched the new Commissioner’s National Priority Voucher pilot program under which it could issue vouchers to companies aligned with major national priorities, such as meeting a large unmet medical need, reducing downstream health care utilization, or addressing a public health crisis.
The new program will convene experts from the regulator’s offices for a team-based review, instead of using the standard review system, where a drug application is sent to numerous FDA offices.
Each drug review division within the FDA has been charged with nominating a product while companies can also apply and have their request reviewed, the FDA said on Thursday.
The agency expects to announce another group of products under the new program in the coming months.
Eli Lilly’s experimental weight-loss pill, orforglipron, could be fast-tracked under the new voucher process, analysts had speculated last month. The FDA’s list on Thursday did not include orforglipron.
Lilly called the program a promising initiative adding, “while it’s too early to discuss how this submission pathway might relate to any of our specific programs, we look forward to learning more from the Administration,” the company said in an emailed response.
Published on October 17, 2025
